Phase 3
Completed N=2,370
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Chronic Idiopathic Constipation
Source: ClinicalTrials.gov NCT01919697 ↗
Enrolled (actual)
2,370
Serious AEs
1.7%
Results posted
Jul 2019
Primary outcomePrimary: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) — 123; 620 Participants
◆ Published Evidence
Established
23citations · ~3 / year
Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.
Summary
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Linked Publications
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Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) |
123; 620 | — |
| PRIMARY Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide |
14; 111 | — |
| PRIMARY Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) |
121; 122.9; 75.7; 76.5 | — |
| PRIMARY Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) |
71.2; 71.9 | — |
| PRIMARY Summary of Vital Signs at >Day 364 - Body Temperature (°C) |
36.62; 36.59 | — |
| PRIMARY Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) |
15.7; 16.0 | — |
| PRIMARY Summary of ECG Results Shift From Baseline at > Day 364 |
27; 42; 15; 44 | — |
| PRIMARY Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline |
192; 1498 | — |
| SECONDARY Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 |
1.8; 1.7 | — |
| SECONDARY Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 |
1.8; 1.7 | — |
| SECONDARY Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 |
4.1; 4.2 | — |
| SECONDARY Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment |
4.1; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
- Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.
Exclusion Criteria
- Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
- Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- Patient has taken a protocol-prohibited drug without the appropriate washout period.
Data sourced from ClinicalTrials.gov (NCT01919697) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.